Phase 3 Study Comparing HDM1002 Tablets and Dapagliflozin for Adults with Type 2 Diabetes Not Controlled by Metformin

What this Trial Is About

Researchers are evaluating the effects of HDM1002 tablets compared to dapagliflozin in adults with type 2 diabetes mellitus T2DM who are not adequately controlled with metformin. This phase 3, multi-center, randomized, double-blind, active-controlled study aims to assess the efficacy and safety of these treatments. Participants will be stratified based on their baseline glycated hemoglobin HbA1c levels to better understand treatment effects in different subgroups. The study involves a screening period up to 2 weeks, followed by a 4-week metformin run-in before randomization. About 800 participants will be randomized in equal groups to receive one of three doses of HDM1002 tablets starting from 50 mg and escalating every 4 weeks to maintenance doses of 100 mg, 200 mg, or 400 mg or dapagliflozin 10 mg daily for 52 weeks. After treatment, there will be a 4-week follow-up. The primary endpoint is the change in HbA1c at Week 40. Participants will have regular assessments during the study, including measures of blood sugar control HbA1c, fasting plasma glucose, insulin function, body weight, lipid profiles, blood pressure, and diabetes treatment satisfaction. Safety will be monitored through adverse event tracking, laboratory tests, physical exams, and vital signs throughout the 56 weeks of the study. Participants are expected to maintain consistent diet and exercise habits during the trial.

A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus